USE OF BUPROPION IN PREGNANCY

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(Date of issue: March 2018, Version: 3.1)

This is a UKTIS monograph for use by health care professionals. For case-specific advice please contact UKTIS on 0344 892 0909. To report an exposure please download and complete a pregnancy reporting form. Please encourage all women to complete an online reporting form.

A corresponding patient information leaflet on bupropion use in pregnancy is available at www.medicinesinpregnancy.org.

Summary

Bupropion is a noradrenaline and dopamine selective reuptake inhibitor licensed for use as a smoking cessation aid in the UK. In other countries bupropion is also licensed for use at a higher dose as an antidepressant. Much of the available pregnancy exposure data are collected from studies investigating its use as an antidepressant, which limits the conclusions we are able to provide concerning its use as a smoking cessation aid.

Published human pregnancy exposure data do not currently provide evidence of an increased risk of spontaneous abortion, major congenital malformation overall, cardiac malformation overall, intrauterine death, low birth weight or preterm delivery following maternal bupropion use in pregnancy. Although single case-control studies have suggested possible associations with specific cardiac malformations including coarctation of the aorta and ventricular septal defects, these observations have not been replicated in other studies.

One study has provided evidence that bupropion may be associated with an increased risk of ADHD in the offspring of women who were treated with bupropion for depression. However, this finding was based on a small number of exposed infants with ADHD resulting in an imprecise risk estimate which may have been confounded by the underlying maternal condition. This observation therefore requires confirmation in further studies.

Due to the limited efficacy and pregnancy safety data, bupropion is not routinely recommended as a smoking cessation aid for pregnant women. However, each patient needs to be assessed on a case-by-case basis. Where bupropion use in pregnancy is being considered, patients should be made aware of the limited data available and other therapeutic options should be discussed. Exposure to bupropion at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy. However, other risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.

This document is regularly reviewed and updated. Only use full UKTIS monographs downloaded directly from TOXBASE.org to be sure you are using the most up-to-date version. The summaries of these monographs are openly available on UKTIS.org.

This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to health care professionals at www.toxbase.org.

If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.

If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.

Disclaimer: Every effort has been made to ensure that this monograph was accurate and up-to-date at the time of writing, however it cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes of the measures recommended. The final decision regarding which treatment is used for an individual patient remains the clinical responsibility of the prescriber. This material may be freely reproduced for education and not for profit purposes within the UK National Health Service, however no linking to this website or reproduction by or for commercial organisations is permitted without the express written permission of this service. This document is regularly reviewed and updated. Only use UKTIS monographs downloaded directly from TOXBASE.org or UKTIS.org to ensure you are using the most up-to-date version.